Week In Review: WuXi AppTec Acquires US-Global Clinical CRO

WuXi AppTec, China's largest CRO/CMO, will acquire a global clinical-stage contract research company, ResearchPoint Global, of Austin,Texas (see story). Founded in 1999, RPG has 450 employees in 60 countries spread out over Africa, the Americas, Europe and Israel. The company offers a full range of clinical CRO services to small and medium-sized pharmas. WuXi said the acquisition would extend its CRO network around the world. WuXi already has a 500-person China clinical CRO and a clinical research coordinator team with 1,000 employees. Financial details were not disclosed.  

Shenzhen Hepalink (SHE: 002399) announced a US$69 million investment into Canada's Resverlogix (TSX: RVX) via a private placement that will raise Hepalink's stake in Resverlogix to 45% (see story). Resverlogix is currently conducting a Phase III trial of apabetalone (RVX-208), a first-in-class, small molecule BET (bromodomain and extra-terminal) inhibitor. Resverlogix expects RVX-208 to raise a patient's high-density cholesterol. Hepalink began as a global supplier of heparin API, which is sourced from pig intestines.  

Eargo, a Silicon Valley direct-to-consumer hearing aid company, closed the first tranche of a $45 million Series C round, led by Hong Kong's NanFung Life Sciences Fund (see story). The round included investors New Enterprise Associates, Charles and Helen Schwab, and Maveron. Eargo makes a small, nearly invisible hearing aid that it says is comfortable and rechargeable. The device, which costs just under $2,000 per pair, is a Class I, FDA-regulated product.  

Prenetics Limited raised $40 million to expand its pan-Asia DNA testing service aimed at individuals (see story). Prenetics is based in Hong Kongas are Beyond Ventures and the Alibaba Hong Kong Entrepreneurs Fund, the two investment firms that led the round. Currently, Prenetics offers four separate DNA tests, and the company says it has processed nearly 200,000 DNA samples since it was founded in 2015.  

Huawei and Philips announced a China cloud healthcare partnership that uses AI to deliver best diagnostic practices and monitoring in second tier China cities (see story). The partnership combines Huawei's IT capability with Phillips' knowledge of diagnostic scanning devices. The cloud platform will include up-to-date automatic scan readings. It will also include wearable technologies that monitor symptoms outside medical settings and digital records of a person's health. The two companies have begun testing the platform and so far, they are pleased with the results.

GIMDx of Carlsbad, California acquired exclusive China OEM and distribution rights to oncology diagnostic products made by IncellDx, aMenlo Park company (see story). GIMDx will supply raw materials to its corporate parent, Guangzhou Improve Medical Instruments, which Improve will distribute. The products include IncellDx's proprietary single cell quantification of Programmed Death Ligand 1 (PD-L1) on tumor cells and immune cell subtypes, among other tests. Improve Medical will be the first China company to offer a quantitative PD-L1 assay. Financial details of the agreement were not disclosed.  

Trials and Approvals

CStone Pharma of Suzhou has dosed the first patient in a Phase I trial of its anti-PD-L1 monoclonal antibody (see story). The company claims CS1001 is China's first fully human and full-length PD-L1 candidate. Founded in late 2014, CStone has become a clinical-stage pharma in under two years, a remarkably short time. In July 2015, CStone announced a $150 million Series A funding from three China VCs, one of which is WuXi Healthcare Ventures. WuXi AppTec has China rights to the Ligand OMT transgenic animal platform that was used to generate CS1001.  

Chi-Med (Hutchison China MediTech) (AIM/Nasdaq: HCM) and AstraZeneca (NYSE: AZN) presented positive safety and efficacy data of their partnered drug, the c-MET inhibitor savolitinib (see story). Savolitinib was administered together with one of two AstraZeneca drugs -- Tagrisso® (osimertinib) or Iressa® (gefitinib) -- in two Phase Ib/II proof-of-concept trials in patients with non-small cell lung cancer. The patients had failed an earlier first-line treatment with an EGFR inhibitor. The most advanced savolitinib study is a recently started Phase III trial as a first-line treatment in patients with papillary renal cell carcinoma.  

FibroGen (Nasdaq: FGEN), a US-China biopharma, reported the CFDA has accepted an NDA to review its novel anemia treatment for Chinaapproval (see story). Roxadustat is a first-in-class oral treatment for anemia in patients undergoing kidney dialysis. The China review is the first filing for the candidate. In 2013, FibroGen formed a 50/50 joint venture with AstraZeneca, which signed a $357 million deal to co-develop roxadustat in China. The China acceptance of the NDA triggers a $15 million payment to FibroGen.  

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